Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Thursday, March 31, 2016

Nine years ago, three top executives of Purdue Pharma pleaded guilty to criminal charges of "misbranding" Oxycontin. The case appeared to be a landmark. In previous years, top executives of large health care corporations rarely faced legal consequences when their companies misbehaved. Yet in the Purdue Pharma/ Oxycontin case, things were not what they seemed. Maybe that is why this case never did yield a new era of accountability for top corporate health care leaders.

Background - the Oxycontin Guilty Pleas

In 2007, we posted about the executives' guilty pleas. Relying on the New York Times coverage, we noted that the Department of Justice charged that the company used aggressive, deceptive marketing, including claims that Oxycontin had little potential for addiction, even though they then knew otherwise. Unlike many other settlements, the executives and the company admitted their dishonesty, although they were not apparently charged with fraud.

In a statement, the company said: 'Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health care professionals that were inconsistent with the F.D.A.-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information.'

'We accept responsibility for those past misstatements and regret that they were made,' the statement said.

While no executives went to jail, the three who pleaded guilty,

Michael Friedman, the company’s president, who agreed to pay $19
million in fines; Howard R. Udell, its top lawyer, who agreed to pay $8
million; and Dr. Paul D. Goldenheim, its former medical director, who
agreed to pay $7.5 million.

appeared to be the top leaders of the company. So, at the time I concluded,

At least in the Purdue Pharma/ Oxycontin case top company leaders were
prosecuted, pleaded guilty, and will personally have to pay substantial
financial penalties. Maybe this will convince the leaders of health care
organizations that deceptive marketing practices may not be in their
long term interests. Up to now, it may have been too easy to be swayed
by the enormous profits deceptive marketing can bring, and regard fines
paid by the company as just a cost of doing business.

Meanwhile, Purdue Pharma has been in the news since 2007, and not in a good way. In particular, we noted that the company seemed to keep up manipulative, if not deceptive marketing efforts on behalf of its narcotic product. In 2010, Canadian medical students protested that their "education" about narcotics and pain management was influenced by Purdue marketing (look here). In 2012, we noted that a leading "key opinion leader" who had a key role promoting the liberalized, if not reckless use of narcotics to treat all sorts of chronic pain, and had financial relationships with numerous narcotic pharmaceutical manufacturers, including Purdue Phrama, later admitted that it was all "misinformation." Yet this aggressive promotion of narcotics was likely a major factor in the ongoing narcotic epidemic which has killed thousands in the US. And in January, 2016 we described how opposition to new CDC guidelines that suggested much more conservative use of narcotics seemed to be funded, if not orchestrated by narcotic pharmaceutical manufacturers, notably including Purdue Pharma. Finally, there have been many other stories about Purdue Pharma about which we failed to post.

One would think, however, that a company that admitted to a crime, and whose three top executives lost their jobs and also pleaded guilty to crimes, would at least change its ways, even if these guilty pleas and admissions did not inspire more attempts to hold top corporate health care leaders accountable.

An Assumption about Unaccountable Hired Mangers

But it turns out that some obvious assumptions that I and probably many other people made about the Purdue Pharma cases of 2007 were wrong. I implicitly assumed when I wrote my 2007 post that the three Purdue Pharma executives who pleaded guilty were the top leaders of the company.

Furthermore, as we have discussed elsewhere, the top executives of large, for-profit publicly held corporations, like most pharmaceutical companies, have become largely unaccountable. They may seem to exist in a bubble, in which they are hailed as visionaries, and paid exceedingly well no matter how their organizations perform. (Look here). However, many top hired corporate managers have mainly become "value extractors."

These executives are nominally accountable to their corporate boards of directors, which are supposed to represent the owners of the companies. However, most large pharmaceutical companies have numerous stockholders, who have no easy avenue to organize. Many of their stockholders, in turn, are mutual funds, retirement funds, etc whose shares in turn are owned by thousands more. These numerous, dispersed "owners" have little influence on corporate boards, who often functionally are dominated by cronies of the top management.

So when the three top Purdue executives pleaded guilty, at least it looked like in this case the unaccountable hired executives had been made accountable, if not to their boards of directors, at least to the courts.

But Who Owned Purdue?

But what you see is not always what you get. There was a hint buried in the NY Times article,

Between 1995 and 2001, OxyContin brought in $2.8 billion in revenue for Purdue Pharma, a closely held company based in Stamford, Conn. At one point, the drug accounted for 90 percent of the company’s sales.

As part of the plea agreement, Purdue Frederick, a holding company for Purdue Pharma that is also closely held, pleaded guilty to a felony charge of misbranding OxyContin.

The article did not further discuss the meaning and implications of the twice used phrase, "closely held." I confess I missed it entirely. However, it seems to have meant that rather than being a public corporation with numerous, dispersed stockholders, the owners of Purdue Pharma and its parent were a smaller group, perhaps a group who should have been accountable for the actions of their executives. However, the NY Times did not further describe this group. Neither did reports in other outlets, such as the Wall Street Journal, CBS, or Time. Nor did a variety of other news stories that mentioned Purdue Pharma through 2010.

The Oxycontin Billionaires

There were a fewother clues available in 2007, but would have not been easily found at that time. After the case's resolution was disclosed, an article appeared in the Corporate Crime Reporter (but was presumably only available at that time by subscription.)

Purdue is a privately held, very secretive company based in Stamford, Connecticut.

It’s controlled by the Arthur Sackler family. Arthur Sackler is the guy who, before he delivered OxyContin, brought to you the marketing for Librium and Valium. Walk on the mall in Washington and you walk by the Freer Gallery of Art and Arthur Sackler Gallery.

Art brought to you by Oxy.

New York Times correspondent Barry Meier is probably the most plugged in journalist on the topic. A couple of years ago, he wrote a book detailing the problem titled Pain Killer: A 'Wonder' Drug’s Trail of Addiction and Death (Rodale Books, 2004.)

So apparently Purdue Pharma and Purdue Frederick were privately held, the Sackler family held a controlling interest, and the Sackler family were rich enough to have their name attached to an art museum.

The relationship between the Sackler family and Purdue got no other attention I could find until 2010. In March of that year, another member of the family, Dr Mortimer D Sackler died, and his NY Times obituary led off with evidence of his wealth, and philanthropy,

Mortimer D. Sackler, a psychiatrist who was a co-owner of the pharmaceutical company Purdue Pharma, makers of the controversial painkiller OxyContin, and whose lavish gifts to the Guggenheim Museum, the Metropolitan Museum of Art and Columbia University made him one of New York City’s most prominent benefactors, died March 24 in Gstaad, Switzerland. He was 93 and had homes in London, Gstaad and Antibes, France.

The obituary also provided evidence of a direct relationship among the Sacklers, Purdue, and the development of Oxycontin.

The Sackler brothers were all doctors, and all businessmen as well. In 1952, while the three were working at the Creedmoor state psychiatric hospital, Arthur financed the purchase of a small drug manufacturer based in Greenwich Village, the Purdue Frederick Company, which Mortimer and Raymond Sackler ran as co-chairmen and which later became Purdue Pharma, now based in Stamford, Conn.

Then,

by the mid-1990s Purdue Pharma was still a small drug company. But with a new product, OxyContin, a powerful, long-acting, narcotic painkiller, the company hoped to join the ranks of industry giants. Indeed, by 2001 sales of the drug had reached nearly $3 billion and accounted for 80 percent of Purdue Pharma’s revenue.

The lavish scale of Sackler's generosity was indicated in The Sunday Times's "Rich List" for 2008, which noted that while he and his family owned a £500 million stake in the pharmaceutical business, Purdue Pharma, huge charitable contributions had cut their wealth to £300 million. Yet few knew much about the Sacklers apart from their association with the cultural institutions that bear their name.

However, I could find no echos of this story beyond these obituaries, and certainly none that prominently made their way into the health care world. In late 2011, about ten percent of a long piece by Fortune on Purdue made the Sackler's ownership and wealth clear, but did not discuss the implications.

The story only began to echo a little in 2014. That year, the prospect of a trial of a civil lawsuit against Purdue filed in the state of Kentucky, one of the most hard hit by the narcotic epidemic, promised to shake things up. A long Bloomberg story on the lawsuit was the first to suggest that the very wealthy Sackler family might bear some responsibility for how Purdue marketed Oxycontin, and the results on patients' and the public's health.

Kentucky lawyers plan another first for Purdue: They want to elicit testimony from the company’s board, which is dominated by members of the Sackler family, the wealthy philanthropists who own the company and have until now remained largely untouched by the controversy tied to the blockbuster drug that netted their business billions of dollars.

It underlined the tightness of the ties between the Sackler's and Purdue. The family does not merely own a controlling interest, but dominates the company's governance.

Purdue today is owned through holding companies and family trusts for the benefit of Mortimer and Raymond Sackler’s families, according to Raul Damas, a company spokesman. In all, nine members of the Sackler family are Purdue directors. In January, Raymond Sackler announced the appointment of Chief Executive Officer Mark Timney. None of the Sacklers has been named in the Kentucky suit.

Raymond, who remains on the board, and his children have been the most involved in the family business. His son, Richard, a physician, worked at Purdue for three decades before being named president in 1999. Now retired, he remains a director. A grandson, David Sackler, sits on the board and runs a family investment fund, Summer Road LLC, in New York. Raymond’s other son, Jonathan, is a director, too.

By the way, the Bloomberg article also detailed another point (which had been mentioned in the obituaries and the CNN article). One member of the Sackler family was behind the aggressive, deceptive marketing campaign that sparked so many sales of Oxycontin. In fact, this Sackler brother could be viewed as the father of modern aggressive, deceptive pharmaceutical/ biotechnology/ device corporate marketing.

Raymond and Mortimer ran the company together. Arthur, the oldest, appears to have been primarily an investor and adviser.

Considered the father of modern pharmaceutical marketing, Arthur Sackler created the first medical-journal advertising insert to promote a drug and pushed for hiring sales reps long before they became as common in physicians’ waiting rooms as out-of-date magazines. Purdue used many of Arthur Sackler’s tactics when it introduced OxyContin, a time-released dose of the opioid oxycodone, in 1995.

CNN had gone into a bit more detail on Arthur Sackler's previous work:

Arthur, joined a small advertising agency that specialized in marketing pharmaceuticals. (He also funded his brothers’ purchase of Purdue, according to a 2003 book by New York Times reporter Barry Meier called Pain Killer: A Wonder Drug’s Trail of Addiction and Death.) Arthur was so successful that in 1997 he was one of the first people named to the Medical Advertising Hall of Fame, whose website credits him with helping 'shape pharmaceutical promotion as we know it today.' As early as the 1950s he was experimenting with TV marketing, and according to the entry, Arthur’s scientific knowledge and ability to expand the uses for Valium helped turn it into the first $100 million drug ever. Arthur’s philosophy was to sell drugs by lavishing doctors with fancy junkets, expensive dinners, and lucrative speaking fees, an approach so effective that the entire industry adopted it.

So at least this article credits Dr Arthur Sackler, of Purdue Pharma, with being one of the creators of the web of conflicts of interest that has ensnared many medical professionals in the last decades. Who knew?

Just to ice this cake, in later 2015, it became apparent that the Sacklers did not merely become wealthy from Purdue profits and Oxycontin sales. They became fabulously wealthy. Forbes listed the Sackler family that year as one of the 20 richest US families, estimating their combined wealth as $14 billion.

The Sackler family, which owns Stamford, Conn.-based Purdue Pharma, flew under the radar when Forbes launched its initial list of wealthiest families in July 2014, but this year they crack the top-20, edging out storied families like the Busches, Mellons and Rockefellers.

How did the Sacklers build the 16th-largest fortune in the country? The short answer: making the most popular and controversial opioid of the 21st century — OxyContin.

Purdue, 100% owned by the Sacklers, has generated estimated sales of more than $35 billion since releasing its time-released, supposedly addiction-proof version of the painkiller oxycodone back in 1995.Its annual revenues are about $3 billion, still mostly from OxyContin. The Sacklers also own separate drug companies that sell to Asia, Latin America, Canada and Europe, together generating similar total sales as Purdue’s operation in the United States.

Forbes estimates that the combined value of the drug operations, as well as accumulated dividends over the years, puts the Sackler family’s net worth at a conservative $14 billion.

Perhaps if the Kentucky lawsuit had gone to trial, these echos would have gotten even louder.

However, in December, 2015, Purdue settled the suit for $24 million, admitting no liability, and keeping the Sackler name out of the limited press coverage (although see this in STAT by Ed Silverman.)

I, for one, only found out about the Sackler / Purdue linkage when STAT published a followup in March, 2015. It turns out that in the run up to the Kentucky trial, a member of the Sackler family was actually deposed. This may have been the only direct discussion of the Oxycontin case by a member of the family.

The settlement required the attorney general to 'completely destroy' or return to Purdue all documents it received from the company or from any other party through a subpoena. The attorney general was given 60 days from the Dec. 18 agreement to comply. The agreement also prohibits the attorney general from sharing the documents with any other entity investigating or litigating against Purdue.

The attorney general’s office destroyed millions of pages of documents within the 60-day period, according to spokesman Terry Sebastian.

While the attorney general destroyed the records in its possession, copies of some of those records remain under seal in the Pike County courthouse, including the Sackler deposition.

The STAT article noted that millions of pages of records from other Oxycontin litigation were destroyed or returned to the company as stipulated by previous settlements. This time,

STAT is making a motion to intervene in the settled Kentucky lawsuit. The motion was sent to the Pike Circuit Court Monday via overnight courier.

The motion argues that STAT and the public have a constitutional right to the records that trumps Purdue’s interest in keeping them secret. The motion also states there is a substantial public interest in the case, citing the epidemic of drug addiction and related crime stemming from the abuse of OxyContin in Kentucky and other states. STAT is requesting the court make the documents available immediately.

We will see how this attempt to shine a little light on the long running Oxycontin story goes. I am not optimistic, since this long-running case has vividly shown how those who have the biggest vested interests in keeping our commercialized, overutilizing, over-marketed health care system going can use money and influence to keep it all so anechoic.

Summary

So now we see, dimly, reasons why the penalties handed out to "top" Purdue Pharma executives for the deceptive "misbranding" of a dangerous narcotic failed to end the impunity of top health care leaders. Those supposed "top men" were not really the top.

Just like in "Raiders of the Lost Ark,"

They were hired managers with fancy titles who worked for a secretive family which owned Purdue Pharma, which was apparently directly involved in the engineering of the aggressive, deceptive, "misbranding" sales campaign which sold so much Oxycontin, which became fabulously wealthy from the ownership of the company, and which managed to conceal their relationship to the company from nearly all prying eyes. So far, the family seems to either have befuddled or intimidated law enforcement sufficiently to prevent any direct consequences from befalling them.

This case vividly demonstrates, first, how those who have personally gained the most from our current dysfunctional health care system have often brilliantly covered up what they were doing (part of what we have called the anechoic effect). As long as we do not know where the money goes, and how it is made, we do not know what needs to be done to make things better. True health care reform requires bright sunlight to be shown on how the health care sausage is made, who makes it, and how they profit from it. As long as we the people let ourselves stay in the dark, we will continue to endure our woefully overpriced, inaccessible, mediocre quality, and all too often frankly corrupt health care system.

A piece this long and heavy deserves a musical interlude. Here is a live performance by the Dramatics of "What You See Is What You Get," (if only that were the case here).

For a second day, the region’s second-largest health care system deals with a crippling computer virus. MedStar Health says it is making progress, but WJZ is learning some patients are still feeling the effects.

... Despite the challenges affecting MedStar Health’s IT systems, the
quality and safety of our patients remains our highest priority, which
has not waned throughout this experience. Fortunately, the core ways in
which we deliver patient care cannot be altered, manipulated or harmed
by malicious attempts to disruptthe services we provide[that is, by taking down the EHRs -ed.],” Stephen R.T.
Evans, MD, executive vice president, Medical Affairs and chief medical
officer, MedStar Health. “Our ability to serve our patients and their
families depends first and foremost on our caregivers, and their expert
knowledge and compassion focused on each patient.”

MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient
clinics in the D.C. and Baltimore area lost access to their EHRs Monday
and Tuesday when the GE Centricity EHR system crashed. The system went
offline for scheduled maintenance on Friday and had come back on Monday
when it suffered a “severe” malfunction, according to an email from
Medstar management that was shared with Morning eHealth.

“All of a
sudden the screens lit up with a giant text warning telling us to log
off immediately,” a doctor said. “They kept saying it would be back up
in an hour, but when I left work Tuesday night it was still down.”

This
doctor told us that the outage was “disruptive and liberating at the
same time. I wrote prescriptions on a pad for two days instead of
clicking 13 times to send an e-script. And I got to talk to my patients
much more than I usually do.

But of course we didn’t have access to any
notes or medication history, and that was problematic.” MedStar notified
clinicians in the email that any information entered in the EHR after
Friday was lost.

WASHINGTON (AP) — Hackers crippled computer systems Monday at a major hospital chain, MedStar Health Inc., forcing records systems offline for thousands of patients and doctors. The FBI said it was investigating whether the unknown hackers demanded a ransom to restore systems.

A computer virus paralyzed some operations at Washington-area hospitals and doctors’ offices, leaving patients unable to book appointments and staff locked out of their email accounts. Some employees were required to turn off all computers since Monday morning.

A law enforcement official said the FBI was assessing whether the virus was so-called ransomware, in which hackers extort money in exchange for returning a victim’s systems to normal. The official spoke on condition of anonymity because the person was not authorized to discuss publicly details about the ongoing criminal investigation.

Not discussed is corporate accountability for deficient IT security.

“We can’t do anything at all. There’s only one system we use, and now it’s just paper,” said one MedStar employee who, like others, spoke on condition of anonymity because this person was not authorized to speak to reporters.

I note that if the cybernetic pundits were listened to, patients would now be considered at deadly risk due to paper records being used - not due to critical IT infrastructure being hacked and disabled. Yet it's impossible to disable paper charts en masse.

MedStar said in a statement that the virus prevented some employees from logging into systems. It said all of its clinics remain open and functioning and there was no immediate evidence that patient information had been stolen.

When asked whether hackers demanded payment, Nickels said: “I don’t have an answer to that,” and referred to the company’s statement.

Dr. Richard Alcorta, medical director for Maryland’s emergency medical services network, said he suspects it was a ransomware attack. He said his suspicion was based on multiple earlier ransomware attempts on individual hospitals in the state. Alcorta said he was unaware of any ransoms paid by Maryland hospitals or health care systems.

The rather calmly-stated "multiple earlier ransomware attempts on individual hospitals in the state" suggests that

Hospitals are being targeted in an organized fashion, and

Costs to implement proper security will draw even more capital and resources from direct patient care and from real brick and mortar facilities, such as entire new hospital wings that would cost less than an EHR, to cybernetics of increasingly dubious value. (Past projected cost benefits are certainly being proven even more naive.)

Terrorism or just plain old crime, the medical driector asks...

“People view this, I think, as a form of terrorism and are attempting to extort money by attempting to infect them with this type of virus,” he said.

God help us if true terrorists get in the act of cybernetically paralyzing hospitals.

Alcorta said his agency first learned of MedStar’s problems about 10:30 a.m., when the company’s Good Samaritan Hospital in Baltimore called in a request to divert emergency medical services traffic from that facility. He said that was followed by a similar request from Union Memorial, another MedStar hospital in Baltimore. The diversions were lifted as the hospitals’ backup systems started operating, he said.

It used to be that patient diversions were due to doctors and nurses having too many sick patients they are caring for. Here it seems due to doctors having to many sick computers to deliver proper patient care.

MedStar operates 10 hospitals in Maryland and Washington, including the MedStar Georgetown University Hospital, along with other facilities. It employs 30,000 staff and has 6,000 affiliated physicians.

That's a lot of paralysis.

Monday’s hacking at MedStar came one month after a Los Angeles hospital paid hackers $17,000 to regain control of its computer system, which hackers had seized with ransomware using an infected email attachment.

Hollywood Presbyterian Medical Center, which is owned by CHA Medical Center of South Korea, paid 40 bitcoins — or about $420 per coin of the digital currency — to restore normal operations and disclosed the attack publicly. That hack was first noticed Feb. 5 and operations didn’t fully recover until 10 days later.

Hospitals are considered critical infrastructure, but unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted.

I won't even comment on why a US hospital is owned by a Korean medical center. The statement "unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted" implies yet another blind spot in the unregulated health IT industry. Add that to the blindness towards close-calls and actual harms, and you have a field being pushed on the population under penalty by those somewhat deaf, dumb and blind to the downsides.

Computer security of the hospital industry is generally regarded as poor, and the federal Health and Human Services Department regularly publishes a list of health care providers that have been hacked with patient information stolen. The agency said Monday it was aware of the MedStar incident.

All I can hear is "ka-ching! ka-ching!" as the costs to fix the poor computer security in the hospital industry accrues.

How much will patient care suffer as a result of the diversion of yet more resources to cybernetics?

[1] I've written that paper for many clinical settings, including highly specialized forms as I implemented highly successfully in invasive cardiology (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), needs reconsideration, relieving clinicians of clerical work and employing data entry clerks to enter the data. This would be supplemented by far less expensive document imaging systems for 24/7 availability, and computerized lab results retrieval - the latter with appropriate humans on the receiving end to prevent the "silent silo" syndrome of lab results returned to a computer silo but missed by clinicians due to being very busy and due to unreliable/fatiguing cybernetic alerting. A lot of workers can be paid for by saving $50 or $100 million on software.

MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient
clinics in the D.C. and Baltimore area lost access to their EHRs Monday
and Tuesday when the GE Centricity EHR system crashed. The system went
offline for scheduled maintenance on Friday and had come back on Monday
when it suffered a “severe” malfunction, according to an email from
Medstar management that was shared with Morning eHealth.

“All of a
sudden the screens lit up with a giant text warning telling us to log
off immediately,” a doctor said. “They kept saying it would be back up
in an hour, but when I left work Tuesday night it was still down.”

This
doctor told us that the outage was “disruptive and liberating at the
same time. I wrote prescriptions on a pad for two days instead of
clicking 13 times to send an e-script. And I got to talk to my patients
much more than I usually do.

But of course we didn’t have access to any
notes or medication history, and that was problematic.” MedStar notified
clinicians in the email that any information entered in the EHR after
Friday was lost.

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker’s Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group’s recreational activities such as a Niagara Falls excursions, $150 in 'walking around' money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club. It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without "admitting or denying the findigs." In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

'The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,' Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case. Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders. Yet this evidence remains anechoic, even given the apparent recidivism involved. For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership. At that time, our post included these section headings covering 2014-15:

Furthermore, in that post we also documented Novartis' previous record. In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing
how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also, in 2013, Novartis was fined for anti-competitive practices in
its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here) Other Novartis misadventures from 2010 and earlier appear here. So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers. Meanwhile, Novartis executives continue to be paid handsomely. The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty. Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7 million in 2013-14 just to US physicians. The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University, Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School. I am unaware that anyone of them have publicly raised any concerns about Novartis' recent misadventures, although I am also unaware whether anyone has publicly asked them such questions.

No wonder that ordinary US (and other countries' citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders. No wonder that someone of them are seeking the protection of some of those powerful insiders. But I digress...

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first...

There seems to be increasing recognition that the continuing rise in US
health care costs is unsustainable, and that these costs are not buying
us good health care. There are calls to avoid unnecessary, and
sometimes harmful care. Yet there is a persistent disconnect between
how continuing dishonest behavior by health care organizations, impunity
of their leaders, and lack of accountability by their board members
fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the
causes of the current dysfunction. Recognizing how health care
dysfunction is created by unaccountable, dishonest leadership should
lead to true reform that would promote well-informed, honest,
accountable leadership that puts patients' and the public's health ahead
of personal gain.

Sunday, March 20, 2016

In 2015, we noted (here and here) that the New England Journal of Medicine seemed to have been reduced to publishing rants about "pharmascolds" who are paranoid about conflicts of interest. Now there they go again....

Background

The sad story about the risks of power morcellation for the treatment of fibroids has received considerable media attention. The state of play through July, 2014 was described in a series of articles in the Cancer Letter of July 4, 2014. (Look here.)

Uterine fibroids are a common affliction of women. Their preferred surgical management had changed from open surgery to minimally invasive surgery, sometimes robotically performed, and often incorporating a device called a power morcellator to pulverize the fibroids, allowing the use of small incision. However, after a patient at the Brigham and Womens' Hospital (BWH) in Boston, part of the Partners Healthcare system, was found to have disseminated sarcoma post power morcellation, most likely because the machine spread tumor cells throughout her abdomen, the US Food and Drug Administration (FDA) issued an advisory against using the procedure morcellation, and despite some controversy, the procedure is now uncommonly used.

The patient so severely affected was Dr Amy Reed, an anesthesiologist at the BWH. Her husband, a cardiothoracic surgeon at BWH, launched a campaign to reduce the use of power morcellation. His pursuit of this campaign underlined an important part of the history,

The use of power morcellation was effectively allowed by the FDA in the absence of any controlled trials meant to assess its safety or efficacy in this context. The device was deemed moderate risk and approved through the 510(k) process because it appeared similar to previously allowed devices, even though older devices were not used to remove fibroids. The Cancer Letter quoted Dr David Challoner, who was on a relevant Institute of Medicine (IOM) committee, saying allowing the device on the market was

one more example of the clearance of a
device for a use, not approval, based on predicates already in the
market, that is, prior morcellators for other uses

The New England Journal of Medicine Weighs In - with a Special Pleading

Once again, NEJM national correspondent Dr Lisa Rosenbaum had a contrarian view(1). As we discussed here and here, last year Dr Rosenbaum wrote three commentaries suggesting the importance of conflicts of interest in health care had been overblown, especially with respect to medical journals.

This time, she argued that the FDA overreacted to the tragic case of Dr Amy Reed. In particular, she was afraid that the risks of power morcellation were exaggerated, and based on poor quality data,

Several experts argued that these risk estimates were too high and that it was riskier to expose 100,000 or so women per year to open procedures rather than laparoscopic ones. Since the rarity of LMS precludes a randomized trial, however, risk estimates had to be based primarily on retrospective case series of varying rigor. Some studies were poorly stratified for risk factors such as age, and others spanned decades during which diagnostic criteria for LMS had changed.

Dr Rosenbaum failed to mention that the lack of good data about the risks of power morcellation stemmed from the lack of any large, well designed randomized controlled trials done to assess its benefits and harms. Of course, since the device's use was allowed by the FDA 510(k) process without any requirement for trial data, there was no incentive for device companies, at least, to do such trials.

Nonetheless, Dr Rosenbaum also argued the benefits of power morcellation were downplayed.

the benefits of morcellation are largely invisible and thus 'unavailable.' Who sees the women who undergo a minimally invasive procedure, recover quickly, and avoid losing income? What does a pulmonary embolus, a wound infection, or a hemorrhage that didn’t happen look like? You can’t post pictures of these nonevents on social media. But their nonoccurrence is why we ought to be celebrating.

'She talks about the data concerning the possible harms of power morcellation and argues that that data comes from relatively low-quality studies, not randomized, controlled trials, and that it is hard to tell the actual rate of harms, in particular, the dissemination of cancer. On the other hand, Dr. Rosenbaum implies that the benefits of power morcellation are well known.'

'She writes initially that power morcellation allows the treatment of fibroids to be ‘done more efficiently and effectively,’ she later implies that power morcellation is less invasive, leads to quicker recovery, avoids income loss, and furthermore, reduces the likelihood of pulmonary embolus, wound infection, or hemorrhage.'

'However, she doesn’t provide any data about these ostensible benefits. A quick search suggested that there are no good randomized, controlled trials that assessed benefits. Her argument that we have abandoned a beneficial treatment based on poor quality and perhaps exaggerated the data about its harms—that does not seem to be supported by any clear data about its benefits.'

I rendered that opinion on March 18 before I read a Cochrane Collaboration review of minimally invasive surgery versus open surgery for fibroids(2). However, that review does not seem to contradict my statements above. The review included some patients who were treated using power morcellation, but apparently did not find any studies that assessed patients treated only with power morcellation with those treated only with an alternative. Even so, it only included nine studies that enrolled a total of 808 patients. Thus, I think it is reasonable to say that there have not been any large, well-done randomized controlled trials of power morcellation versus other treatments of fibroids. Even so, while the review found some advantages for minimally invasive surgery versus open surgery in terms of short-term post-operative pain and length of hospital stay, it did not address pulmonary embolus, wound infection, or hemorrhage directly. So while Dr Rosenbaum was right to say that the evidence from clinical research about the magnitude and nature of harms of power morcellation was relatively weak, the evidence about its benefits is also weak. Thus, Dr Rosenbaum's argument that the harms have been exaggerated while the benefits were overlooked was based on a logical fallacy, special pleading.

This special pleading seemed the basis for her claim that

women may suffer more from its [power morcellation's] disuse.

So, as I was quoted by the Cancer Letter,

'The NEJM is perhaps the most prestigious, most highly regarded English-language medical journal in the world,' Poses said. 'It is, in many cases, viewed as the standard for scholarly medical journals. I am a bit surprised that it published a commentary by its own national correspondent that appears to make an argument—about benefits and harms of treatment and policymaking about treatment—that does not have a clear discussion of the data that support or fail to support either the benefits or the harms of the treatment.'

More Arguments, Less Justification

Dr Rosenbaum insisted that her concerns were about the question,

How do you use data to clarify tough trade-offs when the most compelling narratives paint evidence-based reasoning itself as an anathema?

However, she did not demonstrate an approach to policy making on power morcellation that was more evidence-based than what has transpired so far.

In addition, Dr Rosenbaum decried challenges to health care innovation from "the power of tragic stories," and the title of her commentary ("N-of-1 policymaking") suggested that the the FDA approach to power morcellation was based on a single tragic story. Yet an FDA spokesperson insisted in the March 18, 2016 Cancer Letter article,

The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 14, 2014 decision.

Furthermore, Dr Rosenbaum expressed concerns that power morcellation met its "demise" because of unwarranted concerns about the "greedy corporation," "medicine's corruption," and "industry greed." Yet she ignored arguments that these concerns were not unreasonable.

First, the commentary ignored claims that power morcellation procedures were very lucrative, e.g., those in the 2014 Cancer Letter article

Nor did she argue against the assertion in the same article that device companies used political influence to promote their very expensive product,

There is a very strong pressure from the device industry to get into the market quickly.

The device companies have been able to make [the 510(k) process that allowed power morcellation] survive politically over the ensuing 40 years.

Also, Dr Rosenbaum's NEJM commentary failed to counter the assertion by Dr Noorchashm that the device manufacturers concealed the risks of power morcellation.

Device manufacturers clearly knew of the cancer risk. You can see warnings about malignant tumors in the Ethicon and Karl Storz user manuals. Clearly, their lawyers had warned them to put them there to avoid liability. The bottom line is that these manufacturers knew of this hazard, but neither reported it back to the FDA, as would have been the safe and responsible thing to do.(3)

Finally, according to the March 18, 2016 Cancer Letter article, while Dr Reed has apparently sued the BWH, and Dr Rosenbaum admitted she is on "faculty" at the BWH, neither she, the NEJM, nor the BWH will say whether she is currently being paid by the BWH. Particularly,

the hospital declined to provide information on Rosenbaum's title and whether she is a full-time faculty member, citing personnel policies.

My response (in the Cancer Letter article) was

'I can see that the hospital would not want to reveal her salary, if in fact she has one, and that has privacy implications,' Poses said. 'But I don’t understand why the hospital would not be able to simply tell you whether or not she is employed there and in what capacity.'

Thus, the latest commentary in the New England Journal of Medicine by National Correspondent Dr Lisa Rosenbaum used special pleading to argue for an expensive medical device with dubious benefits but which no more dubious evidence suggests may cause cancer. The commentary also decried the device's critics as unreasonably concerned about "greed" and "corruption," even though the device is clearly expensive, there are at least creditable allegations that the device makers used political influence to promote it and concealed its risks, and ironically the commentary itself obfuscated whether Dr Rosenbaum has a major financial relationship to the hospital that is being sued in connection with use of that device there.

Thus, this latest New England Journal of Medicinearticle, like those by the same author in the same journal which we have discussed before (here and here), seems more like a rant in a political blog than a scholarly article in the US' and perhaps the world's most prestigious scholarly medical journal. What is going on at the NEJM? What has happened to its editorial standards? Why should it continue to inspire such trust?

Thursday, March 17, 2016

I believe the suffering and death of my mother in 2010-2011 due to EHR flaws - including but not limited to lack of essential confirmation dialogs on medication deletion at triage, lack of notification messages informing down-line staff of such action by unqualified personnel (inadequate support of teamwork), and other issues - lends me some moral standing to comment on the following as a horrifying and potentially criminal matter. (See http://khn.org/news/scot-silverstein-health-information-technology/).

Any official in leadership of health IT who denies this - or sidesteps it - or makes excuses for compromises on health IT safety, especially in view of dire warnings from clinician experts - in 2016 is guilty of conduct of the type below:

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person. It generally involves an indifference or disregard for human life or for the safety of people. Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.

Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way. Criminal negligence is less serious than intentional or reckless conduct. Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.

The two articles reflect a good possibility that the politics of what I'd once termed "cybernetics über alles" has trumped patient safety concerns in NYC.

Here's details from the first article:

A new $764 million medical records system is launching at the municipal hospital system on April 2 — even though insiders warn it isn’t ready and patients will suffer.

The soft launch of the electronic system Epic is scheduled at Elmhurst and Queens hospitals.

“Sooner or later, it will crash,” said one source involved in the project. “There will be patient harm — patient harm and patient death.”

That sounds like insiders warning of far more problems than mere crashes causing patient harm and death, a brave act considering possible retaliation.

Sources say Dr. Ramanathan Raju, who runs the municipal network, NYC Health + Hospitals, is under the gun from City Hall to meet the deadline and fears he’ll be fired if he doesn’t.

“Raju has said too many times to count that the Mayor’s Office has told him if April 1st doesn’t happen, then Ram will lose his job,” one source said.

The source added that Raju has threatened to fire top executives if the project doesn’t launch on time.

If this is true, than the "gun" from City Hall is aimed straight at patients, and if patients indeed are mortally affected, the responsible officials might be deemed accessories to murder.

I add that this type of situation represents fundamental and severe mismanagement, as I'd been writing about since the late 1990's at my academic site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/.

Insiders contend that the only safe way to roll out Epic is to take
more time — about three months — to address several key issues.

One is planning for a crash, which some consider almost inevitable
because the new setup hasn’t been configured to work with systems at
other hospitals or with some of its own internal billing and tracking
software.

Existing patient data also has to be transferred from the old system —
a process that would normally take six months, but which was shoehorned
into less than one.

Going "live" with a half-baked EHR under such circumstances for political reasons, if these facts are true, would be, in my professional opinion, an act worthy of prison time if harm results.

“There are supposed to be all these dry runs,” a source said. “They haven’t been done.”

Again, if true, this reflects expediency at the expense of patient well-being, by rows of political hacks, fools and incompetents calling the shots in an area in which they have no business being involved.

City officials contend Epic remains “on-time and within budget.”

I have a feeling this will be revisited at some time in the future - in court.

A mayoral spokeswoman said there would be a round-the-clock effort to ensure there are no glitches.

"No glitches?"

That is a hollow promise that cannot be kept even under the best of circumstances. Under the hellish circumstances described, such a statement is outright frightening. The Mayor truly has no clue about EHR "glitches", but I offer the many posts at query link http://hcrenewal.blogspot.com/search/label/glitch for his education.

Mr. Mayor, here's an example of EPIC and other EHR implementations under the best of circumstances. These systems are so immensely complex, trying to be pressure-fit into a vastly complex, varying and changing environment, that to not heed CMIO and other expert warnings is the height of recklessness:

Of course, we are reassured that the crack team assigned the implementation duties will produce stellar results:

“NYC Health + Hospitals and its Epic implementation experts are
prepared to implement the new system in Queens facilities beginning
April 2, and have assembled a team of about 900 technicians and Epic
experts who will work around-the-clock that week both in Queens and at
remote data centers to ensure the transition to the new system goes as
smoothly as possible,” said spokeswoman Ishanee Parikh.

EPIC experts like these? From this link at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:

Epic Staffing Guide

A
reader sent over a copy of the staffing guide that Epic provides to
its customers. I thought it was interesting, first and foremost in that
Epic is so specific in its implementation plan that it sends customers
an 18-page document on how staff their part of the project.

Epic
emphasizes that many hospitals can staff their projects internally,
choosing people who know the organization. However, they emphasize
choosing the best and brightest, not those with time to spare. Epic
advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

I
bet many readers were taught by their HR departments to do behavioral
interviewing, i.e. “Tell me about a time when you …” Epic says that’s
crap, suggesting instead that candidates be given scenarios and asked
how they would respond. They also say that interviews are not
predictive of work quality since some people just interview well.

Don’t
just hire the agreeable candidate, the guide says, since it may take
someone annoying to push a project along or to ask the hard but
important questions that all the suck-ups will avoid.

The
part about "not worrying about relevant experience" and about "hiring
recent college graduates as HIT project analysts" is bizarre if true, and downright
frightening.Medical environments and clinical affairs are not playgrounds for novices,
no matter how "smart" their grades and test scores show them to be.
These practices as described, in my view, represent faulty and
dangerous advice on first principles. The
advice also is at odds with the taxonomy of skills published by the
Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

In a “resignation and thank-you” email last week, Dr. Charles Perry
urged colleagues at NYC Health + Hospitals — formerly the Health and
Hospitals Corp. — to sound the alarm and press for an “external review”
to stop the system from going live next month.

Perry was chief medical information officer of Queens and Elmhurst
Hospital Centers, the first scheduled to get the new electronic medical
data system.

When a CMIO - a role I held in the mid 1990s - resigns under such circumstances, a project should be halted in its tracks and external examination begun. Instead, it appears we have spin control.

In his email, Perry offered a comparison to the launch of the Challenger —
aboard which seven crew members died when it exploded 73 seconds after
liftoff on Jan. 28, 1986 — and cited a presidential panel’s report
examining how the disaster occurred.

That is as dire and direct a warning as they come. Unqualified individuals who second guess such a warning should be held legally accountable for adverse outcomes.

(Such a warning letter about EHRs now sits as "Exhibit A" in the lawsuit complaint regarding my dead mother. It had not been heeded.)

“For a successful technology, ­reality must take precedence over public
relations, for nature cannot be fooled,” Perry wrote in his ­email,
quoting from the report.

But fools in leadership roles in health IT think they can fool Mother Nature.

Perry went on to urge a short delay despite “vehement entreaties to
make the April 1st date by officials and consultants with jobs and
paydays on the line.”

This is exactly how patients end up maimed and dead.

Agency president Dr. Ramanathan Raju has repeatedly told colleagues
his job is on the line if the deadline isn’t met, sources said.

Perry, a medical doctor with an MBA, declined to comment.

Maybe Raju should quit, too. He should know that Discovery over such matters would not be very pleasant, especially if I am assisting attorneys in such matters - which could very well occur.

“He [Perry] took a stand,” said one insider. “He wasn’t going to take part in something that was going to compromise patient safety.”

It's good to know someone in Medical Informatics still has balls.

The idea that we’d jeopardize patients to meet a deadline is simply
wrong,” said Karen Hinton, Mayor Bill de Blasio’s spokeswoman.

“If a patient safety issue is identified, the project will stop until it is addressed.

“NYC Health + Hospitals and its Epic implementation experts have
assembled a team of about 900 technicians and Epic experts who will work
around the clock through the week surrounding the transition in both
Queens and at remote data centers to ensure we shift to the new system
as smoothly as possible.”

It's been said that one expert who truly know what they're doing will always outperform 1,000 (or 900) generalists following the finest of "process" who are in over their heads (to wit, 900 generic musicians could never exceed the work of Beethoven or Brahms).

In this matter, I take the CMIO's word over the 900 techies and "experts", once having voiced such concerns myself.

-- SS

What is Criminal Negligence?

Under some criminal law
statutes, criminal negligence is defined as any type of conduct that
“grossly deviates” from normal, reasonable standards of an ordinary
person. It generally involves an indifference or disregard for human
life or for the safety of people. Sometimes the definition for criminal
negligence also requires a failure to recognize unjustifiable risks
associated with the conduct.
Examples of criminally negligent behavior may include knowingly
allowing a child to be in very dangerous conditions, or driving in an
extremely irresponsible way. Criminal negligence is less serious than
intentional or reckless conduct. Generally, reckless conduct involves a
knowing disregard of risks, while negligence involves an unawareness of
the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law
statutes, criminal negligence is defined as any type of conduct that
“grossly deviates” from normal, reasonable standards of an ordinary
person. It generally involves an indifference or disregard for human
life or for the safety of people. Sometimes the definition for criminal
negligence also requires a failure to recognize unjustifiable risks
associated with the conduct.
Examples of criminally negligent behavior may include knowingly
allowing a child to be in very dangerous conditions, or driving in an
extremely irresponsible way. Criminal negligence is less serious than
intentional or reckless conduct. Generally, reckless conduct involves a
knowing disregard of risks, while negligence involves an unawareness of
the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law
statutes, criminal negligence is defined as any type of conduct that
“grossly deviates” from normal, reasonable standards of an ordinary
person. It generally involves an indifference or disregard for human
life or for the safety of people. Sometimes the definition for criminal
negligence also requires a failure to recognize unjustifiable risks
associated with the conduct.
Examples of criminally negligent behavior may include knowingly
allowing a child to be in very dangerous conditions, or driving in an
extremely irresponsible way. Criminal negligence is less serious than
intentional or reckless conduct. Generally, reckless conduct involves a
knowing disregard of risks, while negligence involves an unawareness of
the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law
statutes, criminal negligence is defined as any type of conduct that
“grossly deviates” from normal, reasonable standards of an ordinary
person. It generally involves an indifference or disregard for human
life or for the safety of people. Sometimes the definition for criminal
negligence also requires a failure to recognize unjustifiable risks
associated with the conduct.
Examples of criminally negligent behavior may include knowingly
allowing a child to be in very dangerous conditions, or driving in an
extremely irresponsible way. Criminal negligence is less serious than
intentional or reckless conduct. Generally, reckless conduct involves a
knowing disregard of risks, while negligence involves an unawareness of
the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law
statutes, criminal negligence is defined as any type of conduct that
“grossly deviates” from normal, reasonable standards of an ordinary
person. It generally involves an indifference or disregard for human
life or for the safety of people. Sometimes the definition for criminal
negligence also requires a failure to recognize unjustifiable risks
associated with the conduct.
Examples of criminally negligent behavior may include knowingly
allowing a child to be in very dangerous conditions, or driving in an
extremely irresponsible way. Criminal negligence is less serious than
intentional or reckless conduct. Generally, reckless conduct involves a
knowing disregard of risks, while negligence involves an unawareness of
the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

Wednesday, March 09, 2016

We have noted that increasing numbers of physicians provide patient care as employees of large organizations, often hospital systems, sometimes for-profit. Since in these settings physicians must answer to generic management which may be more concerned with short-term revenues than patient care, these new arrangements are frought with hazards for physicians and patients.

One set of hazards may be found in the contracts employed physicians must sign.

My fellow blogger, Dr Wally Smith, and I authored an article just published online "How Employed Physicians' Contracts May Threaten Their Patients and Professionalism." Here is the link.

In it we listed multiple contractual provisions that may be found in employed physicians contracts that may threaten professionalism and good patient care:

Confidentiality clauses - which may hide quality and safety problems, medical errors, unethical conduct, other problematic contract clauses, and malfeasanceProductivity clauses - which may provide incentives for actions that primarily increase employers' revenues, and thus may encourage overtreatment"Leakage control" clauses - which may discourage referrals outside of the employers' systems and thus discourage appropriate referrals for particular patients, potentially threatening qualityClauses that allow termination without cause - which may reduce access for the terminated physicians' patients, and may discourage complaints by physicians about quality, safety, unethical behavior, or malfeasanceNoncompete clauses - which may reduce access and physicians' ability to leave unsatisfactory positionsClauses that restrict outside activites - which may restrict teaching or research, or academic freedom or free speech

We also noted clauses in contracts that employers may sign with third parties that may also threaten professionalism and good patient care:

We were able to find cases illustrating all the clauses published in the news media, or publications such as Medscape or Medical Economics. However, they have largely anechoic in the scholarly medical and health services literature, and largely unaddressed by the medical societies that ostensbibly protect physicians' professionalism and patients' and the public's health.

We suggested that such contractual problems may be becoming more frequent in a health care system in which physicians more often are corporate. We suggested that all physicians confronted with new employment contracts should seek competent legal connsel and try to negotiate egregious provisions. However, such actions may now be futile given the increasing market dominance of the hospital systems that are employing increasing numbers of physicians.

We urged medical societies to inform physicians about such employment issues, and better support physicians who struggle with them. However, these contract problems may merely be a reflection of an increasingly commercialized, deregulated health care system run by generic managers who may put revenue generation ahead of supporting physicians' professionalism. So, better enforcement of existing laws, and new laws including bans on the commercial practice of medicine may be the only solutions to this newly recognized plight of corporate physicians and their patients.

Thursday, March 03, 2016

On Health Care Renewal, we frequently discuss deceptivemarketing schemes designed to sell tests and treatments whose benefits for patients do not clearly outweigh their harms, and sometimes which are useless or dangerous. In fact, we have to be selective about discussing such cases, because they are all too common. Therefore, we tend to focus on cases involving the biggest and most powerful health care organizations, and/or the worst risks to patients.

We have generally not discussed the myriad promotions of dubious "nutritional" tests and therapies, because there are just so many of them, the players involved are generally small, and these products were effectively deregulated in the US by the 1994 Dietary Supplement Health and Education Act. However, last year we discussed how the marketing of a "nutritional supplement" containing an amphetamine like substance was seemingly facilitated by the revolving door at the US Food and Drug Administration (FDA).

The Trump Network -Background

But a story recently republished by Stat is now suddenly relevant because one of the players involved is now so influential. It recounted the rise and fall of The Trump Network, a network marketing scheme to sell nutritional products.

Actually, the most colorful version of the background of this story comes from a 2011 article in New York Magazine. Here is how the network marketing worked, using an example centered around a Trump Network marketer-to-be named Izzo:

He would order the vitamins from a company called Ideal Health. She
would earn a commission on the sale and he, in turn, would become a part
of her team and encourage other people to buy the vitamins. For those
sales, Izzo would earn a commission, as would she (his 'upline'), and
then the people he sold the vitamins to would become part of his
sales team and would go on to create their own sales teams, who would
go on to create their own sales teams, etc., ad infinitum, all of them
funneling commissions from their sales up to Izzo and the woman on the
phone. As he listened, 'something clicked,' Izzo says. 'I saw the beauty
of the business model. And I said, ‘How can I do this, and do this
big?’ '

The idea was so big it was picked up by no other than "The Donald" Trump.

'The name is hot!” Donald Trump booms over the speakerphone from his office at 725 Fifth Avenue, where, ever since The Apprentice breathed
new life into his brand, he has presided over an ever-diversifying
array of businesses. He is, of course, speaking of his own name. “It’s
on fire!”

In March 2009, Trump
purchased Ideal Health, rebranding it the Trump Network. Though the
packaging has now been imprinted with the Trump family crest, the
product line is still much the same. There are the two multivitamins:
Prime Essentials and the more expensive Custom Essentials, the
ingredients of which are determined by the Trump Network–branded
PrivaTest, a urine test that claims to determine which vitamins the user
needs. There’s also a line of healthy snacks for kids called Snazzle
Snaxxs, QuikStik energy drinks, and a Silhouette Solutions diet program.
With the Trump investment, the company has added a skin-care line that
goes by the seductively foreign name BioCé Cosmeceuticals.

Back then, Mr Trump thought the sky would be the limit.

Next year, the Trump Network plans to add more products and extend
its reach to Europe and Asia. The goal, Trump says, is to eventually
become bigger than Amway, now an $8.4 billion company and the giant in
the field. Whether or not the people of Laos will spring for a skin-care
line from a man famous for his perma-tan, some Long Islanders seem
convinced.

“People have said,
‘This is Donald Trump’s network-marketing company? I want in,’ ” says
Alex, Izzo’s pretty 29-year-old daughter, who quit her job and moved
back in with her parents last year in order to become a marketer, as the
people in the network call themselves. “I was talking to a woman the
other day and she said, ‘If I can’t trust Donald Trump, who can I
trust?’ And I said, ‘You’re totally right.’ ”

As Stat noted, Trump helped market the network with great enthusiasm back then.

Donald Trump was ready to make some money on vitamins.

On a Friday night in November 2009, Trump stood before a crowd of
thousands at the Hyatt Regency in Miami to launch a new enterprise, The
Trump Network. Behind him was a gigantic image of his family crest and
an enormous photograph of himself.

'We’re gonna come out with new and different products,' Trump told the crowd. 'They’re gonna be wonderful products.'

Marketing videos that include Mr Trump are still readily available online,

In the video, Mr Trump said"Americans need a new plan. They need a new dream. The Trump Network means to give millions of people a new hope."

The Problems with the Trump Network

Well, how did that work out?

The Stat article described the Network's big product:

The Trump Network asserted that it could use a urine test to recommend customized nutritional supplements, its signature products. It also offered products that purportedly tested for allergies and bone health.

In particular,

The Trump Network sold many health and wellness products, and its main one was a customized nutritional supplement whose composition was determined by a urine test, called the PrivaTest.

A former marketer provided STAT with a kit for Ideal Health’s PrivaTest. It contained a urine collection cup, five test tubes, a cold pack, a biohazard bag, a prepaid FedEx mailing label, and detailed instructions. Customers collected their urine and shipped it to a lab for analysis. That lab analyzed the urine with three tests and produced a report, which was sent to The Trump Network.The Trump Network bundled the report with a package of pills and shipped it all back to the customer. The pills were marketed as 'Custom Essentials,' formulations based on the results of the test and manufactured by another lab. In all, there were 48 formulations.

According to an archived version of The Trump Network’s website that can still be found online, the PrivaTest, along with a month’s worth of the Custom Essentials, cost $139.95. Retesting was available for $99.95, plus shipping and handling. The company recommended retesting every nine to 12 months.

The problem is that there is no evidence that these products, particularly PrivaTest, worked in any sense. First, there appeared to be no publicly available data on how the tests worked, what they actually tested, or how accurate they were. Then there was no data about how the test results could rationally be used to suggest particular mixes of vitamin supplements. Also, there was apparently no public data about what vitamins were in the potions sent to consumers, their purity, their strength, etc.

Worse, there was no evidence that any of this provided any benefits to the people who ended up taking the vitamins.

To support the necessity of supplements, The Trump Network’s website
cited a 2002 article from the Journal of the American Medical
Association. The article, it said, 'stated that every adult needs to
supplement their nutrition to remain healthy.'

But the article also specifically cautioned against the types of products that The Trump Network sold. 'The Internet and health food stores are filled with promotions for
these special-purpose multivitamins, which are often costly,” the
article said. “The only evidence-based arguments for taking more than a
common multivitamin once a day pertain to the elderly and women who
might become pregnant.'

The JAMA article warned against tests that claimed they can help consumers determine which vitamins they should take.

Worse,

While the FDA may not have evaluated the tests or supplements, independent scientists have — and raised many questions.

Cohen, one of several scientists who reviewed materials from Ideal
Health and The Trump Network, said that the tests were marketed too
broadly and seemed to be 'pathologizing normal human life.'

The website, for example, recommended its “AllerTest”
to anyone who had dark circles under their eyes, occasional digestive
problems, fluctuating blood sugar, sinus and respiratory problems, or
tiredness after eating.

'Does your blood sugar fluctuate?' Cohen said, laughing. 'If your
blood sugar does not fluctuate, you are extremely ill. You will not be
long on this planet.'

What’s more, the AllerTest did not measure food allergies, as the network’s website claimed it would, according to outside analysis of materials from the testing lab and Ideal Health publications.

The test measured information about an antibody known as
immunoglobulin G, or IgG, according to company publications. The
antibody is normally produced in the body and not indicative of a food
allergy, said Dr. Robert Wood, director of pediatric allergy and
immunology at Johns Hopkins School of Medicine.

'There’s no disease condition for which the IgG antibodies have any relevance at all,' Wood said.

So while Mr Trump, his company, and some of his marketers might have made money from the Trump Network, there is no evidence that its products actually provided any health benefits.

Also, in the long run, Mr Trump's grandiose claims about how the riches his new marketers would receive also proved wanting. Despite Trump's initial enthusiasm, the Trump Network hardly went global,

Regardless of the science, Trump’s name did wonders for Ideal Health
in the short term. Former marketers said the company grew significantly
in the months following the name change.

Then, the network began experiencing financial difficulties.

'The Trump Network had gotten in trouble financially,' said Bonnie
Futrell, a former marketer and 'diamond director' — one of the top-tier
marketers in the company. 'They weren’t being able to pay [the lab].
They weren’t paying vendors. They weren’t paying us.'

Futrell said she was involved in discussions with company higher-ups about how to salvage the organization.

On Dec. 31, 2011, the license agreement expired, said Garten, the
general counsel for The Trump Organization. It was not renewed.

Note that this story was also summarized in an AP article available via CBS. The Network's products were also reviewed, not favorably, on QuackWatch.

Summary

The Trump Network sold nutritional testing and products any clear evidence that they provided any benefits to patients, or that they worked at all in any sense. Some of the products, like the allergy test discussed above, did not appear to be what they were advertised to be. Since the Network's products and the outcomes of people using them apparently never were the subject of any clinical research, whether the products did any harm is unknown. Thus, the Network was like many other dodgy efforts to sell totally unproven "nutritional" products. Its main results seem to have been transferring money from the pockets of the gullible to the marketers, and to Mr Trump himself. While Mr Trump recruited marketers with boastful assertions of giving people "new hope," that hope was false.

The increasing commercialization of health care, enabled by deregulation justified by market fundamentalism, now means that health care has become increasingly a means of transferring money from the little people to big corporations, in this example, those corporations owned by Mr Trump, without providing any net health benefit to those whose pockets have been invaded. This is bad enough.

But at the moment, Mr Trump is considered the front runner for the Republican presidential nomination, although he is attracting more enmity, much of it from the Republican party. It is ironic that Mr Trump seems to be winning support from a lot of "little people" whom he has promised to defend. Yet it was the little people who marketed the Trump Network and bought its products who were eventually left hanging.

The Stat article mentioned that some minor candidates for the Republican nomination this year were also tarred with stories about their involvement in questionable health marketing schemes. And previous major party candidates have certainly had some health care conflicts of interest. In fact, we discussed that the current First Lady once was a top executive of a big hospital chain, and the last Republican presidential candidate was a leader of a private equity firm that owned numerous health companies. It may be unprecedented, at least in recent history, for someone who
had been directly involved in the shady marketing of dubious health
remedies to be a genuine contender for the US presidency.

There are many bigger issues in the current election than health care. But now we are faced with Mr Trump, who once hawked unsubstantiated health benefits of dodgy nutritional products, and recruited marketers for these products with false promises of wealth to come. And Mr Trump has some real possibility of becoming the President of the US, to whom the Department of Health and Human Services, and the Department of Veterans Affairs report. What damage could such a leader do to health care? And what other damage could a man who so cavalierly fleeced the little people with his dubious nutritional product marketing scheme do, especially to the little people who now so unconditionally support him?

Is there a better example showing why we as a society need to completely rethink who gets to become our leaders? My only hope is we can do that rethinking in time to prevent a disaster.

Contributors

Contact Us

Email: info at firmfound dot org
or go to the web-site for FIRM - the Foundation for Integrity and Responsibility in Medicine

More About FIRM and Health Care Renewal

FIRM - the Foundation for Integrity and Responsibility in Medicine is a 501(c)3 that researches problems with leadership and governance in health care that threaten core values, and disseminates our findings to physicians, health care researchers and policy-makers, and the public at large. FIRM advocates representative, transparent, accountable and ethical health care governance, and hopes to empower health care professionals and patients to promote better health care leadership.

FIRM depends on contributions from individuals and non-profit organizations. FIRM does not accept any direct support from for-profit health care corporations.

FIRM welcomes support from individuals and non-profit organizations. If you are interested in donating to FIRM, please email info at firmfound dot org, snail mail us at 16 Cutler St, Suite 104, Warren, RI, 02885, USA, or see our web-site.

Upcoming Meetings and Events

Subscribe To Health Care Renewal

Policies: Blog Roll and Comments

Our blogroll is meant to include blogs that provide interesting content relevant to what we write. It is not an endorsement in any way of any specific blog.

We accept comments, especially from registered Blogger users. If you do not wish to register with Blogger, we will accept anonymous comments, although prefer that they contain identification of the commenter.

We encourage thoughtful comments relevant to the issues brought up by the posts on Health Care Renewal.

All comments are moderated. We will reject spam, profanity, advertising of products or services not directly related to the content of this blog.

We will reject any unsubstantiated accusations or allegations.

Nonetheless, all comments represent only the opinions of those making them. The appearance of comments does not imply endorsement by the Health Care Renewal bloggers.

Please email general comments about the blog, other concerns, or questions to info AT firmfound DOT org